NCT01674712 - A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease | Biotech Hunter

Enrollment

575

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions

Dyslipidemia

Interventions

DRUG

Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks

DRUG

Simvastatin 20 mg

Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks

DRUG

Fenofibrate 145 mg

Fenofibrate, tablet, 145 mg, once daily, 12 weeks

DRUG

Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks

DRUG

Simvastatin 40 mg

simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Trial Locations (69)

3000

Site Reference ID/Investigator# 77955, Santa Fe

Site Reference ID/Investigator# 77962, Santa Fe

7600

Site Reference ID/Investigator# 77961, Buenos Aires

8324

Site Reference ID/Investigator# 77966, Cipolletti - Rio Negro

10117

Site reference ID/Investigator # 97356, Berlin

10242

Site reference ID/Investigator # 80115, Bucharest

10249

Site Reference ID/Investigator# 90673, Berlin

11172

Site Reference ID/Investigator# 80114, Bucharest

11794

Site Reference ID/Investigator# 80117, Bucharest

12351

Site Reference ID/Investigator# 80100, Berlin

13125

Site reference ID/Investigator # 97357, Berlin

14059

Site Reference ID/Investigator# 80095, Prague

18081

Site Reference ID/Investigator# 80093, Prague

20054

Site Reference ID/Investigator# 80116, Bucharest

20253

Site reference ID/Investigator # 99902, Hamburg

22328

Site Reference ID/Investigator# 80119, Bucharest

40113

Site Reference ID/Investigator# 80096, Ústí nad Labem

40597

Site Reference ID/Investigator# 80102, Düsseldorf

42122

Site Reference ID/Investigator# 80113, Bucharest

44137

Site reference ID/Investigator # 102017, Dortmund

45200

Site Reference ID/Investigator# 77974, Zapopan

45355

Site Reference ID/Investigator# 80104, Essen

45359

Site Reference ID/Investigator# 80103, Essen

47574

Site Reference ID/Investigator# 80101, Goch

51069

Site reference ID/Investigator # 102016, Cologne

60594

Site Reference ID/Investigator# 80105, Frankfurt

65691

Site reference ID/Investigator # 102335, Brno

76199

Site reference ID/Investigator # 102015, Karlsruhe

119435

Site Reference ID/Investigator# 80135, Moscow

119620

Site Reference ID/Investigator# 80137, Moscow

119991

Site Reference ID/Investigator# 80124, Moscow

125284

Site Reference ID/Investigator# 80127, Moscow

150010

Site Reference ID/Investigator# 80125, Yaroslavl

194156

Site reference ID/Investigator # 80134, Saint Petersburg

197022

Site reference ID/Investigator # 80126, Saint Petersburg

Site reference ID/Investigator # 80128, Saint Petersburg

199106

Site Reference ID/Investigator# 80136, Saint Petersburg

630008

Site Reference ID/Investigator# 80122, Novosibirsk

630047

Site Reference ID/Investigator# 80121, Novosibirsk

630068

Site Reference ID/Investigator# 80133, Novosibirsk

650002

Site Reference ID/Investigator# 80120, Kemerovo

700547

Site Reference ID/Investigator# 80118, Iași

B1605DSX

Site Reference ID/Investigator# 77957, Buenos Aires

B1657BHD

Site Reference ID/Investigator# 77958, Buenos Aires

B1722COV

Site Reference ID/Investigator# 77960, Buenos Aires

B1878GEG

Site Reference ID/Investigator# 77959, Buenos Aires

B2800DGH

Site Reference ID/Investigator# 77969, Buenos Aires

C1179AAB

Site Reference ID/Investigator# 77967, Buenos Aires

C1181ACK

Site Reference ID/Investigator# 77968, Buenos Aires

C1405BCH

Site Reference ID/Investigator# 77965, Buenos Aires

Unknown

Site Reference ID/Investigator# 77956, Buenos Aires

4000JCU

Site Reference ID/Investigator# 77963, San Miguel de Tucumán

S2000DSV

Site Reference ID/Investigator# 77964, Santa Fe

294 71

Site reference ID/Investigator # 99617, Benátky nad Jizerou

656 91

Site Reference ID/Investigator# 80097, Brno

108 00

Site Reference ID/Investigator# 80094, Prague

415 01

Site Reference ID/Investigator# 80098, Teplice

669 02

Site Reference ID/Investigator# 80099, Znojmo

01069

Site reference ID/Investigator # 99876, Dresden

C.P. 44130

Site Reference ID/Investigator# 77970, Guadalajara, Jal.

C.P. 06600

Site Reference ID/Investigator# 77973, Mexico City

C.P. 11850

Site Reference ID/Investigator# 77972, Mexico City

80-952

Site Reference ID/Investigator# 80111, Gdansk

Site Reference ID/Investigator# 80112, Gdansk

81-423

Site Reference ID/Investigator# 80110, Gdynia

40-954

Site Reference ID/Investigator# 80106, Katowice

09-400

Site Reference ID/Investigator# 80109, Płock

96-100

Site Reference ID/Investigator# 80108, Skierniewice

01-868

Site Reference ID/Investigator# 80107, Warsaw